Health Trials

Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)

ConditionsPost-mastectomy Pain SyndromeBreast CancerPain, PostoperativePain, Chronic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity Health Network, Toronto

About this trial

Phase III, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old

Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)

Disqualifiers

Previous breast surgery within 6 months of index surgery

Undergoing any autologous flap procedure during index surgery

Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery

Documented hypersensitivity or allergy to lidocaine

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lidocaine 20mg/ml

    Drug

    Patients in the intervention group will receive an IV lidocaine infusion using a dosage regimen of 1.5 mg/kg bolus of a 2% lidocaine solution with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room).

  • Placebo

    Drug

    Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution) until the end of surgery (and up to 30 minutes into recovery room).

Treatment groups

1,602 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Development of persistent pain 3-months after breast cancer surgery

Persistent pain at 3-months

Time frame
3- months

Secondary outcomes

1

Pain intensities

Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement.

Time frame
3 and 12 months
2

Opioid consumption

Morphine-equivalent opioid consumption

Time frame
3 and 12 months
3

Moderate-to-severe persistent pain

Defined as persistent pain with an NRS pain score of ≥4 at rest 24-hours

Time frame
3 and 12 months
4

Persistent neuropathic pain

Measured using the Douleur Neuropathique 4-symptoms interview

Time frame
3 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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